MS relapse

The U.S. Food and Drug Administration (FDA) has agreed to review Alkermes’ request to approve diroximel fumarate (BIIB098) as a treatment for relapsing forms of multiple sclerosis (MS), the company announced. A final decision by the FDA is expected in the fourth quarter of 2019. If approved, diroximel…

Stable patients with multiple sclerosis (MS) who transition from Tysabri (natalizumab) treatment to Aubagio (teriflunomide) have a lower relapse risk, a new study shows. The study, “Reducing return of disease activity in patients with relapsing multiple sclerosis transitioned from natalizumab to teriflunomide: 12-month interim results of teriflunomide therapy,”…

Relapses can be sneaky. They can scythe you down. I’ve been dealing with multiple sclerosis (MS) since 2006 and I only consciously remember two relapses. The first relapse was two years after I had been diagnosed with sclerosis. There was the possible hope from my first neurologist that nothing…

Multiple sclerosis patients who began treatment with Gilenya and stayed with it continuously showed a more than 50 percent reduction in annual relapse rates, a real-world study following these people for up to three years found. Gilenya, marketed by Novartis, is an oral disease-modifying treatment for relapsing-remitting multiple sclerosis , approved in 2010. It acts by binding and modulating receptors — called sphingosine-1-phosphate receptor — on lymphocytes (adaptive immune cells). By binding to these receptors, Gilenya prevents lymphocytes from leaving the lymph nodes and reaching the brain and spinal cord, and so lower lymphocyte-induced inflammation and damage. Although several clinical trials have reported reduced annualized relapse rates (ARRs) upon treatment with Gilenya, few long-term real-life studies have examined the relapse rate reductions over a long term. A team, led by Novartis researchers and a scientist at Central Texas Neurology Consultants, collected MS patient data from the MarketScan database, a U.S. claims database including medical and pharmacy claims (bills submitted to health insurance providers), between 2009 and 2016. Among 9,312 MS patients in the database with at least one filled Gilenya prescription, 1,599 adults (mean age, 46) met the study's inclusion criteria, including having at least one inpatient or two outpatient claims, and a total of four years of continuous health plan enrollment. Among these 1,599 patients, all used Gilenya for one year (cohort 1), 1,158 (72.4%) took Gilenya continuously up to the start of year two (cohort 2), and 937 (58.6%) used the therapy up to the start of year three (cohort 3). Baseline analysis — measures taken at the study's start — showed that the most common MS-linked symptoms were disorders of the optic nerve and visual pathways (reported in 22-24%), followed by fatigue/malaise (20-21%). Hypertension (20-21%) and depression (15-16%) were the most common physical and mental comorbidities, respectively. The mean annualized relapse rates (AARs) at baseline in these three groups of patients — cohorts 1 to 3 — ranged between 0.48 and 0.51. A consistent reduction in ARRs was seen in all three groups: cohort 1 had a 0.25 ARR at the close of the first year, for a 51% reduction from the baseline rate; cohort 2 a 0.22 ARR at the start of year two, for a  54% lowering in relapse rates from baseline; and cohort 3 had 0.23 ARR at the third year, amounting to a 53% reduction. As expected, when researchers calculated ARRs among patients with continuous Gilenya use over these three years, they found a greater reduction in annual relapse rates. Mean ARRs in continuous-use patients were 0.19 (a 61% reduction) during the first year, 0.18 (a 62% reduction) during the second year, and 0.18 (a 61% reduction) at the start of the third year. “This retrospective claims database study found that patients with MS who received fingolimod [Gilenya] therapy experienced a durable and sustained reduction in relapse rates over a 3-year period,” the researchers wrote, with findings representing “a durable reduction in relapse rates by [more than] 50%.” Reasons that some patients discontinued treatment were not a focus of this study, they added.

Treatment with Ocrevus (ocrelizumab) has superior or comparable effectiveness and a similar safety profile to other available disease-modifying treatments (DMTs) for treating relapsing multiple sclerosis (MS), according to a new review study. The research, “Systematic review and network meta-analysis comparing ocrelizumab with other treatments for…

My readers have recently brought something to my attention: They informed me that not all MS exacerbations (flare-ups, relapses, and attacks) are created equal. I have learned that along with the hardcore types, which usually require steroid treatment, there are also pseudo-exacerbations. I can always trace the causes of…

Relapsing-remitting multiple sclerosis (RRMS) patients on Gilenya (fingolimod) have fewer relapses and stay on treatment longer than those taking Tecfidera (dimethyl fumarate) or Aubagio (teriflunomide), according to a new study. The research, “Comparison of fingolimod, dimethyl fumarate and teriflunomide for multiple sclerosis,” was published…

At the beginning of each year, I reflect on the one that has just passed. In this column, I’m looking back on my multiple sclerosis (MS) columns from 2018, at some of the most popular topics, and how they affect those of us with MS. My column’s year…

Pretreating multiple sclerosis patients with antihistamines more extensively and with hydration can significantly reduce — by 60% — the likelihood of infusion-associated reactions that are the most common side effect of Ocrevus (ocrelizumab) use, a pilot study reported. Data also found that older and male MS patients are less likely to have…

Many years ago a woman I know who has multiple sclerosis (MS) became pregnant. After her child was born her MS became significantly worse. There have been many studies on the impact of pregnancy on someone with MS, with most concluding that the number of MS relapses are…

Multiple sclerosis (MS) patients who have been relapse-free while using an interferon-beta (IFN-β) therapy but switch to another IFN-β are significantly more like to start experiencing flares than patients who remain on their initial interferon treatment, a real-world study reports. Its results support letting patients remain on a current IFN-β medication…

Living in the U.S., where disease-modifying therapies (DMTs) seem to be prescribed as a matter of course to people with multiple sclerosis (MS), I was surprised that it doesn’t seem to be the case across the pond in the U.K. An article just published on the Multiple…

Tysabri (natalizumab) was found to be superior to interferon beta (IFN-β) in a small, 12-month study with relapsing-remitting multiple sclerosis (RRMS) patients, significantly decreasing their disability levels, its researchers report. A vast majority — 90 percent — of Tysabri-treated patients experienced no relapses during the study period,…

A potentially life-threatening case of bleeding in the lungs has been reported and attributed to treatment with Lemtrada (alemtuzumab) by a woman with relapsing-remitting multiple sclerosis. Her medical team found diffuse alveolar hemorrhage in this patient — which resolved in about a week without treatment. The scientists advised that clinicians be alert…

Patients with relapsing-remitting multiple sclerosis (RRMS) on Rebif (interferon beta 1-a), using the RebiSmart autoinjector, have high treatment adherence, despite seasonal weather or temperature fluctuations, as well as fewer relapses over one year, a real-world study reports. The study, “Seasonal adherence to, and effectiveness of,…

I remember the feeling of having a terrible cold or flu before I had multiple sclerosis (MS). The stuffy nose that made breathing nearly impossible. That elusive tickle in the back of my throat combined with a hacking cough. Cold and flu season is a miserable time, and I…

The U.S. Food and Drug Administration (FDA) has issued a safety alert, warning about a rare but life-threatening risk of stroke and artery rupture in patients with relapsing forms of multiple sclerosis (MS) being treated with Lemtrada (alemtuzumab). Since Lemtrada’s approval in 2014 to treat relapsing MS, 13…

So, “it” started on Monday. I have no idea what I’m dealing with. Is it a urinary tract infection, a relapse, a bird, or a plane? The superhero metaphor is warranted because, just like in “Avengers: Infinity War,” there will be no resolution by the end. Hmm, I’ve…

The U.S. Food and Drug Administration (FDA) has issued a safety alert, warning that people with relapsing multiple sclerosis (MS) who stop using Gilenya (fingolimod) may experience disease worsening beyond that when starting the medicine or while taking it. Reported cases of such increases in MS disability upon stopping treatment are…

I’ve never liked carnival rides (except for roller coasters) because they make me dizzy. Walking sideways, feeling nauseous, and turning green is not my idea of a fun time! So, I go out of my way to avoid anything that can make my head spin. Yet, for some reason,…

Relapse rates in women with multiple sclerosis (MS) decline during pregnancy, as does the use of disease-modifying therapies, before both adjust to pre-pregnancy levels again, a large U.S. study based on real-world data shows. The study, “Relapses and disease-modifying drug treatment in pregnancy and live birth…

Have you ever seen an iceberg? The prism of packed ice illuminates the surrounding sea. The part you can see is beautiful, yet most of its mass lies beneath the surface. You cannot know what you cannot see. Therefore, your perception is based on what is visible. What…

By now you may have heard that actress Selma Blair has revealed that she has multiple sclerosis (MS). That took a lot of guts. Those of us who share her diagnosis might learn a few things from what she’s shared and how she’s shared it. Blair may be…

Asking for assistance is not my favorite thing to do. But frequently, I do ask. The extra help aids in conserving my energy. Some people may feel my energy conservation requests resemble a lazy scam of sorts but, honestly, it’s not. When I ask for a drink of water or…

Please forgive me, but I’m too tired to write tonight. My wife had surgery last week, so I’ve been doing a couple of things that I haven’t done much in the 42 years since our wedding: shopping and cooking. (Well, making Harris Teeter ready-to-heat meals, that is. For…

Merck KGaA announced that evobrutinib, its oral candidate for relapsing multiple sclerosis (MS), was able to safely and significantly reduce active brain lesions over 24 weeks of treatment, according to results of a Phase 2 study sponsored by the company.

Shifting from treatment with Gilenya (fingolimod) to Lemtrada (alemtuzumab), and doing a short washout period between the two therapies, does not seem to increase the risk of disease reactivation in patients with multiple sclerosis (MS), an Italian study shows. Lemtrada, marketed by…

MS PATHS, a way of capturing data on disease progression and treatment response in thousands of multiple sclerosis (MS) patients being treated at any of 10 participating clinics, has among its goals that of making clinical remission — a prolonged absence of any disease activity — possible, said an…

Up to half of women with multiple sclerosis (MS) who stop treatment with Gilenya (fingolimod) when planning to become pregnant will experience a relapse during pregnancy, according to a new study. The findings also revealed relapses over the first six months after giving birth in a quarter of…

Additional analysis of clinical data from Celgene’s investigational agent ozanimod continues to demonstrate its potential to benefit patients with relapsing multiple sclerosis (MS). Findings from the Phase 3 SUNBEAM and RADIANCE Part B trials were discussed at the 34th Congress of the European Committee for Treatment and…